# K011729: Sigma Pace External Pacemaker Analyzer Model #1000

- Pathway: 510(k) (Traditional)
- Applicant: Dni Nevada, Inc.
- Decided: Aug 30, 2001 after 87 days
- Product code: DTC (Analyzer, Pacemaker Generator Function)
- Device class: 2
- Regulation: 21 CFR 870.3630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K903966 (1991). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961582: External Pacemaker Analyzer, Model PMT 100, North American Technical Services Corp. (1996) Summary page 1.
- K903966: External Pacemaker Analyzer Model Pma-1, Bio-Tek Instruments, Inc. (1991) Summary page 1.

## Indications for use
The SigmaPace 1000 External Pacemaker Analyzer is intended for use as regular preventative maintenance and quality assurance checks on external cardiac pacemakers utilized in both the pre-hospital and hospital based environments. The SigmaPace 1000 is limited to preventative maintenance checks for transcutaneous and transvenous types of temporary external cardiac pacemakers. The SigmaPace 1000 will perform a full range of device-specific testing procedures and protocols developed by the external cardiac pacemaker manufacturers. The SigmaPace 1000 will also provide interactive pacemaker simulation capabilities for applications in clinical training and product demonstration. The SigmaPace 1000 is intended to be used by biomedical technicians, OEM manufacturers, and third party service facilities to perform preventative maintenance and quality assurance checks on external cardiac pacemakers, to verify the operation of devices returned from repair, and to assist repair facilities in the diagnosis of intermittent operations. The device may also be used by training facilities to train medical personnel. The SigmaPace 1000 is not used on patients and does not perform any diagnostic, therapeutic, or monitoring functions. Additionally, these devices are not used to test any programmable, implantable pacemakers or any related indwelling cardiovascular catheters or lead wires.

Source page: https://510kreport.com/device/K011729
Methodology: https://510kreport.com/methodology